UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007151 |
|---|---|
| Receipt number | R000008421 |
| Scientific Title | Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH |
| Date of disclosure of the study information | 2012/01/30 |
| Last modified on | 2017/04/11 15:42:12 |
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Basic information
Public title
Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH
Acronym
Clinical investigation of PTH for implanted spinal surgery
Scientific Title
Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH
Scientific Title:Acronym
Clinical investigation of PTH for implanted spinal surgery
Region
| Japan |
Condition
Condition
Osteoporosis with vertebral degeneration
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of PTH to induce bony fusion, decrease pseudoarthrodesis or loosening of pedicle screws, and improve clinical symptoms for aged lumbar degenerative diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Fusion rate
Intervertebral disc narrowing and instability
Appearance rate of screw loosening
Key secondary outcomes
ADL and QOL
femoral bone mineral density
bone metabolic markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide treatment (6 months)
Interventions/Control_2
Non-treatment (6 months)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients with lumbar degenerative disease and surgical indication for one level PLIF or TLIF.
2. Patients limited only female and more than 50 years-old.
3. Patients less than 80% YAM of any site examined by DXA, or patients with fragility fracture at any site, for example on lumbar spine, femur, radius or humerus.
Key exclusion criteria
1) The following patients considered to be at high risk of developing osteosarcoma (bone sarcoma).
-Patients with Paget's disease of the bone.
-Patients with high alkaline phosphatase of unknown cause.
-Patients with history of radiotherapy likely to have affected the bone.
2) Patients with hypercalcaemia.
3) Patients with primary malignant osteosarcoma or metastatic bone tumor.
4) Patients with metabolic bone diseases except osteoporosis (hyperparathyroidism etc.).
5) Patients with a history of hypersensitivity to the constituents of TERIBONE for Subcutaneous Injection or other teriparatide formulations.
6) Women who are pregnant or may become pregnant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Haro, M.D., Ph.D |
Organization
University of Yamanashi
Division name
Department of Orthopaedic Surgery
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL
055-273-6768
haro@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Isogai |
Organization
ASAHI KASEI PHARMA Co.
Division name
Medical Affairs Dept.
Zip code
Address
1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan
TEL
03-3296-3647
Homepage URL
isogai.yb@om.asahi-kasei.co.jp
Sponsor or person
Institute
University of Yamanashi, Department of Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI PHARMA Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shinshu University, School of Medicine, Department of Orthopaedic Surgery
Hamamatsu University School of Medicine, Department of Orthopaedic Surgery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://journals.lww.com/jbjsjournal/subjects/Spine/Fulltext/2017/03010/Role_of_Weekly_Teriparatide_A
Number of participants that the trial has enrolled
Results
Results: Seventy-five patients were randomized to treatment, and 66 patients completed treatment. At 4 months postoperatively, bone fusion in the 2 center CT slices was significantly higher in the teriparatide arm compared with the control arm in the age-adjusted modified intention-to-treat analysis and was significantly higher at 6 months in the per-protocol analysis. Radiographic examinations showed no disc-space narrowing and no intervertebral disc instability. JOABPEQ and ODI results were improved postoperatively in both treatment arms.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 27 | Day |
Last modified on
| 2017 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008421
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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